Tablets & Capsules

TC0719

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12 July 2019 Tablets & Capsules nies will collaborate as part of the agency's pilot project program in support of the Drug Supply Chain Security Act (DSCSA). The pilot project is expected to be completed in the fourth quarter of 2019, and the results will then be published in an FDA DSCSA program report. Briefly noted… Agios Pharmaceuticals, Cam- bridge, MA, received FDA approval for Tibsovo, (ivosidenib) as a treat- ment for newly-diagnosed acute myeloid leukemia with a susceptible IDH1 mutation in patients 75 years and older who have comorbidities that preclude the use of intensive induction chemotherapy. The FDA approved Beximco Pharmaceuticals' anti-allergy product containing cyproheptadine hydro- chloride. The product is a generic equivalent to Periactin, manufac- tured by Merck, Kenilworth, NJ. Cyproheptadine is Beximco's sev- enth FDA-approved abbreviated new drug application. T h e a g e n c y a l s o a p p r o v e d Mavenclad (cladribine) to treat relapsing forms of multiple sclero- sis in adults, to include relapsing-re- mitting disease and active second- ary progressive disease. Mavenclad is manufactured by EMD Serono, Darmstadt, Germany. Abbvie, North Chicago, IL, and Genentech, San Francisco, CA, received FDA approval for Ven- clexta (venetoclax) as a treatment for adult patients with chronic lympho- cytic leukemia or small lymphocytic lymphoma. The agency also approved Abbvie's Mavyret (glecaprevir and pibrentasvir) to treat all six genotypes of hepatitis C virus in children ages 12 to 17. The drug product was previously approved to treat HCV in adults in 2017. thomaspackaging.com We bring solutions to your packaging challenges: Blister Packaging Bottle Filling Pouching Leak Detection Product Recovery '' We went to THOMAS PACKAGING looking for yet another custom solution, and they came through!" . . . . . . . . . Visit us at tabletscapsules.com

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